Binosto

Orange BookUNIISPLATC M05BA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRadius Health, Inc.

CountryUS (United States)

ATC codeM05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7053940004
4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)
ndc11
7053940094
4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)

Annotations

UNII (FDA Substance ID)

2UY4M2U3RA

ALENDRONATE SODIUM

RxCUI 203152

Orange Book

N202344

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2UY4M2U3RA",
    "rxcui": "203152",
    "inchikey": "DCSBSVSZJRSITC-UHFFFAOYSA-M",
    "display_name": "ALENDRONATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "09765234-01bc-40f7-b9bb-c167056f3909": {
      "match": "brand_token",
      "title": "BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [RADIUS HEALTH, INC.]",
      "spl_version": "6",
      "published_date": "2026-02-16"
    }
  },
  "productid": "70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16",
  "productndc": "70539-400",
  "dosage_form": "TABLET, EFFERVESCENT",
  "orange_book": {
    "appl_no": "202344",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 70MG BASE",
        "product_no": "001",
        "approval_date": "Mar 12, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALENDRONATE SODIUM",
  "proprietary_name": "Binosto",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202344",
  "marketing_category": "NDA",
  "nonproprietary_name": "alendronate sodium",
  "start_marketing_date": "20120312",
  "active_numerator_strength": "91.37"
}

Related drugs

Other records sharing ATC code M05BA04.

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